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NCT04452149 · ClinicalTrials.gov registry record · NA
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 826
- Enrollment target
NCT04452149: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT04452149 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 826 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04452149, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 826 participants
- Enrollment target
Study Summary
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure, and to demonstrate the safety of the Reveal LINQ™ system and procedure in the study population.
Primary Outcome
The proportion of PRN medication interventions with one or more associated medication intervention related serious SAEs as adjudicated by the independent Clinical Events Committee will be evaluated. The objective is met when the point estimate for the event rate is less than or equal to 0.05 (5%).
Interventions
- DEVICE Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
- OTHER Medication intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 826 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2025-06-02 |
| Phase | NA |
What the finished NCT04452149 record still lists
NCT04452149 is an interventional study that assigns participants to a tested intervention. The registered 826 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download is the first listed.
NCT04452149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04452149 about?
NCT04452149 is a clinical study titled "Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure". The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic...
What is the current status of trial NCT04452149?
This trial is currently completed. It is a NA study. The enrollment target is 826 participants. The study started on 2020-09-03. Estimated completion is 2025-06-02.
What interventions are being tested in trial NCT04452149?
The interventions under investigation include: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download (DEVICE), Medication intervention (OTHER).
Who is sponsoring clinical trial NCT04452149?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04452149's enrollment target sits among peer trials
826 134th of 2000 higher than 1,867 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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